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CompletedNCT04720820KOMPACTUpdated Jun 19, 2025

Efficacy and Safety of Early Supported Discharge for Post-Acute Stroke Patients in Korea

An interventional study of Early Supported discharge with home based Rehabilitation and Conventional rehabilitation in Stroke, sponsored by Seoul National University Bundang Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-06-19.

Sponsored by Seoul National University Bundang Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
67
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

The study aims to examine the effect of early supported discharge (ESD) service on the functional outcomes and quality of life of acute stroke patients with mild to moderate disability in Korea.

The study is a double-armed prospective multi-centered, assessor-blinded randomized controlled trial comparing the effect of ESD program with conventional rehabilitation program.

Read the detailed description

Early Supported Discharge (ESD) is a form of medical service applicable to acute stroke patients with mild to moderate disabilities. ESD service was developed to facilitate patient to their daily livings at home, reduce the length of stay in the hospital with possibly better or equivalent outcomes for patients and caregivers.

ESD service has been proven to be non-inferior in the functional and quality of life measures as well as cost-effective, compared to the conventional rehabilitation service in many countries, however the effectiveness of ESD service may differ among countries and medical, economical circumstances. This study aims to examine the effect of ESD service on the acute stroke patients with mild to moderate disabilities in Korea and demonstrate its feasibility as an alternative medical service option to those patients.

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Conditions studied

  • Stroke

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Keywords

  • Early Supported Discharge
  • Acute stroke
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 67 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Seoul National University Bundang Hospital is the lead sponsor of 368 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient who is over 20 years old
  • Patient who had acute stroke and admitted to hospital (excludes TIA)
  • Patient who will be discharged to home within 30 days after onset
  • Patient who has indwelling caregiver and is able to support in ESD program
  • Patient who's initial mRS is 1-3
  • Patient who's initial FAC is 3 or above
  • Patient who's initial K-NIHSS consciousness scores (1a,1b,1c) are all 0

Exclusion criteria

Exclusion Criteria:

  • Patient who had Transient Ischemic Attack
  • Patient who is medically unstable requiring intense treatment
  • Patient who has indwelling urinary catheter
  • Patient who is unable to intake food by mouth
  • Patient who is initial MMSE is below 15
  • Patient who has uncontrolled pain
  • Patient who has psychobehavioral problems
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
67 participants (actual)

Study arms

  • Experimental
    Early Supported Discharge (ESD) Group

    Patients in the ESD group will be discharged to home as soon as the acute medical treatment is finished. The patients will follow a pre-planned ESD program which consists of home-based rehabilitation (at least 30 minutes of physical therapy and 30 minutes of occupational therapy per week) offered by therapists. The ESD team will also provide social/medical services as needed. The ESD program will be provided till 1 months after discharge point.

    Other: Early Supported discharge with home based Rehabilitation

  • Active comparator
    Conventional Rehabilitation (CR) Group

    The patients in CR group will be provided with inpatient rehabilitation after the acute medical treatment is finished. The length of inpatient rehabilitation may depend on the hospital's current program. Patients will be provided with outpatient based rehabilitation program if needed after discharge.

    Other: Conventional rehabilitation

Interventions

  • OtherEarly Supported discharge with home based Rehabilitation

    Treatment by Physiotherapist and occupational therapist at least 30 minutes each, per week provided at home.

  • OtherConventional rehabilitation

    Treatment will be provided according to current hospital's stroke rehabilitation program.

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What researchers measure

Primary outcomes

  1. changes in Korean modified Barthel Index (K-MBI)

    K-MBI is an ordinal scale used to measure performance in activities of daily living(ADL). score ranges from 0 to 100, higher score meaning better ADL function.

    Time frame: Baseline, 1 month after discharge, 3 months after onset, changes from baseline

Secondary outcomes

  1. modified Rankin Scale (mRS)

    mRS is a scale used for measuring the degree of disability or dependence in the daily activities of people with stroke. Scale ranges from 0-6, with 0 meaning no symptoms and 6 meaning dead.

    Time frame: Baseline, 1 month after discharge, 3 months after onset

  2. Korean Instrumental Activities of Daily Living (K-IADL)

    K-IADL assesses a person's ability to perform tasks such as using a telephone, doing laundry, and handling finances. The scale ranges from 0 to 100, higher score meaning better IADL function.

    Time frame: 1 month after discharge, 3 months after onset

  3. Korean Reintegration to Normal Life Index (K-RNLI)

    K-RNLI assesses the degree of individuals who have experienced stroke achieve reintegration into normal social activities. The scale ranges from 0-100 with higher score meaning better reintegration to normal life.

    Time frame: 1 month after discharge, 3 months after onset

  4. Patient Health Questionnaire-9 (PHQ-9)

    PHQ-9 is a instrument for screening, diagnosing and measuring the severity of depression. The scale ranges from 0-27 with higher score indicating severer depression.

    Time frame: Baseline, 1 month after discharge, 3 months after onset

  5. Korean Stroke Impact Scale ver 3.0 (K-SIS)

    K-SIS evaluates disability and health-related quality of life after stroke. It consists of 8 domains each score ranges from 0-100 with higher score meaning better quality of life.

    Time frame: 1 month after discharge, 3 months after onset

  6. European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L)

    EQ-5D-5L evaluates the quality of life. The scale ranges from -0.066 to 0.904, lower value means worse quality of life.

    Time frame: Baseline, 1 month after discharge, 3 months after onset

  7. Fall Experience

    Number of patients who experience fall within the period.

    Time frame: 1 month after discharge, 3 months after onset

  8. Mortality rate

    Number of patients who died within the period.

    Time frame: 1 month after discharge, 2 month after discharge(if needed), 3 months after onset

  9. Readmission rate

    Number of patients who were readmitted to the hospital within the period.

    Time frame: 1 month after discharge, 2 month after discharge(if needed), 3 months after onset

  10. Length of hospital stay

    Number of days admitted to hospital for stroke treatment and post-stroke rehabilitation.

    Time frame: 3 months after onset

  11. Korean Zarit Burden Interview-22 (K-ZBI 22)

    K-ZBI 22 assesses caregiver perceptions of burden in health, personal, social or financial domains. The scale ranges from 0-88 with higher score indicating higher burden.

    Time frame: 1 month after discharge, 3 months after onset

  12. Direct costs related to rehabilitation

    Direct costs includes expenses for medical and rehabilitation services. It consists for inpatient cost, outpatient cost, home based rehabilitation cost.

    Time frame: 1 month after discharge, 2 month after discharge(if needed), 3 months after onset

  13. Indirect costs related to rehabilitation

    Indirect costs means expenses needed for treatment and rehabilitation of the patients other tahn medical and rehabilitation services. Indirect costs include transportation expense and caregiver expense and productivity loss

    Time frame: 1 month after discharge, 2 month after discharge(if needed), 3 months after onset

07

Study locations

1 site
  • Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital
    Seongnam-si, Korea, Gyeonggi-do 463-707, Korea, Republic of
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References and documents

Publications

  • Chang WK, Kim WS, Sohn MK, Jee S, Shin YI, Ko SH, Ock M, Kim HJ, Paik NJ. Korean Model for Post-acute Comprehensive rehabilitation (KOMPACT): The Study Protocol for a Pragmatic Multicenter Randomized Controlled Study on Early Supported Discharge. Front Neurol. 2021 Sep 8;12:710640. doi: 10.3389/fneur.2021.710640. eCollection 2021. PubMed 34566853 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04720820
Lead sponsor
Seoul National University Bundang Hospital
Collaborators
Chungnam National University Hospital, Pusan National University Yangsan Hospital
Responsible party
Nam-Jong Paik (Professor, Seoul National University Bundang Hospital) — Principal investigator
First posted
Jan 22, 2021
Start date
Mar 1, 2021
Primary completion
Nov 29, 2023
Completion
Nov 29, 2023
Last update
Jun 19, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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